Senior Design Quality Assurance Engineer
About The Position
As a Senior Design Quality Assurance Engineer at Boston Scientific, you will be instrumental in ensuring the safety, quality, and compliance of our medical devices from concept through commercialization. You will be embedded in a high-performing cross-functional team within the Endoscopy Division, supporting New Product Development, Sustaining Engineering, Life Cycle Management, and Quality Systems initiatives. This role offers the opportunity to influence product direction while enhancing commercial value through technical expertise and quality leadership. This is a hybrid position based out of Marlborough, MA.
Requirements
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field.
- Minimum of 5 years' experience in medical device engineering.
- Detailed understanding of U.S. and international regulatory requirements including 21 CFR Part 820, MDD/EU MDR, ISO 13485, and ISO 14971.
- Ability to travel approximately 10-20%.
Nice To Haves
- Minimum of 6 years' experience in medical device engineering.
- Proficiency with Minitab or equivalent statistical analysis software.
- Six Sigma certification.
- Strong expertise in design controls, quality engineering, risk management, and technical problem-solving.
- Excellent communication and interpersonal skills with proven ability to influence teams and leadership.
- Demonstrated leadership and mentoring capabilities in a quality-driven environment.
- Strategic mindset with the ability to manage hands-on project needs and long-term initiatives.
Responsibilities
- Serve as the primary quality representative within cross-functional product development teams, ensuring adherence to regulatory requirements and quality best practices.
- Lead quality deliverables such as Project Design & Development Plans, Field Assessment Plans, Design Changes, and Design & Usability Validation Plans. Ensure compliance with ISO 14971 and demonstrate a strong commitment to patient safety.
- Lead Risk Management activities and documentation throughout the design process.
- Function as a project leader or specialized technical team lead with cross-functional impact, including division-level representation on cross-divisional quality system initiatives.
- Apply systematic problem-solving tools such as 5 Whys, Is-Is Not, DMAIC, and Six Sigma to drive root cause identification and corrective actions.
- Mentor and coach engineers in quality engineering principles and problem-solving methodologies to promote a culture of learning and continuous improvement.
- Communicate quality priorities and recommendations to stakeholders across departments, using influence and negotiation to integrate quality into strategic decisions.
- Identify and implement improvements to quality systems and practices, championing best-in-class standards.
- Act as a subject matter expert during internal and external regulatory audits; support audit responses and submissions through high-quality technical writing.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Merchant Wholesalers, Durable Goods
Number of Employees
5,001-10,000 employees
